John P. Sfakianos, MD, on the role of urine-based biomarkers in microhematuria evaluation

In February 2025, the American Urological Association (AUA), in collaboration with the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU), released an amendment to the microhematuria guideline.¹

In it, the authors newly recommend the use of validated urine-based tumor markers (UBTMs) in appropriately counseled intermediate-risk patients. For this recommendation, they cite a randomized controlled trial (STRATA; NCT03988309) of CxBladder Triage vs cystoscopy as the highest level of evidence.²

In a recent interview with Urology Times®, John P. Sfakianos, MD, discusses the significance of urine-based biomarkers for intermediate-risk patients and outlines key findings from the STRATA study. Sfakianos is a urologic oncologist at the Icahn School of Medicine at Mount Sinai.

Sfakianos noted, “This is now a tool that allows physician to make better clinical decisions about how invasive we should be, ie, whether a patient should get a cystoscopy or shouldn't [or] whether we have to get further testing or not."

In total, the STRATA study included 135 patients who were randomly assigned to the Cxbladder arm (n = 81) or to the control arm (n = 54).

Notably, the proportion of patients who underwent a cystoscopy in the control arm was 67%, compared with 27% in the study arm, translating to a reduction of 59% with the use of CxBladder Triage. Overall, the test demonstrated a sensitivity 90% (95% CI, 70% to 99%), a specificity of 56% (95% CI, 49% to 56%), a negative predictive value of 99% (95% CI, 95% to 100%), and a positive predictive value of 15% (95% CI, 9% to 22%).

Based on these data, the authors concluded, “In this prospective randomized controlled trial, use of CxbT in patients with [lower risk] hematuria resulted in 59% reduction of cystoscopy use. This clinical utility of CxbT can reduce the burden of unnecessary cystoscopies.”

REFERENCES

1. Barocas DA, Lotan Y, Matulewicz RS, et al. Updates to Microhematuria: AUA/SUFU Guideline (2025). J Urol. 0(0). doi:10.1097/JU.0000000000004490

2. Lotan Y, Daneshmand S, Shore N, et al. A multicenter prospective randomized controlled trial comparing Cxbladder Triage to cystoscopy in patients with microhematuria: The safe testing of risk for asymptomatic microhematuria trial. J Urol. 2024;212(1):41-51. doi:10.1097/JU.0000000000003991